Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

medis, d.o.o. - koncentrat za raztopino za infundiranje - argininijev klorid

Evropska unija - slovenščina - EMA (European Medicines Agency)

astrazeneca ab - moxetumomab pasudotox - leukemija, dlakasta celica - antineoplastična sredstva - lumoxiti as monotherapy is indicated for the treatment of adult patients with relapsed or refractory hairy cell leukaemia (hcl) after receiving at least two prior systemic therapies, including treatment with a purine nucleoside analogue (pna).

Evropska unija - slovenščina - EMA (European Medicines Agency)

merck sharp & dohme b.v. - elbasvir, grazoprevir - hepatitis c, kronični - direct acting antivirals, antivirals for systemic use, antivirals for treatment of hcv infections - zepatier is indicated for the treatment of chronic hepatitis c (chc) in adult and paediatric patients 12 years of age and older who weigh at least 30 kg (see sections 4. 2, 4. 4 in 5. za virus hepatitisa c (hcv) genotip-specifična aktivnost glej točki 4. 4 in 5.

Evropska unija - slovenščina - EMA (European Medicines Agency)

teva b.v.  - clopidogrel (as hydrochloride) - myocardial infarction; peripheral vascular diseases; stroke - antitrombotična sredstva - clopidogrel je navedeno v:izobraževanje odraslih bolnikih, ki trpijo za miokardni infarkt (od nekaj dni do manj kot 35 dni), ischaemic kap (od 7 dni do manj kot 6 mesecev) ali sedež periferne arterijske bolezni. za odrasle bolnike, ki trpijo za akutni koronarni sindrom:non-st segmentu višinskih akutni koronarni sindrom (nestabilna angina pektoris ali ne-q-val, miokardni infarkt), vključno z bolniki, ki opravljajo stent umestitev po perkutani koronarni intervenciji, v kombinaciji z acetilsalicilne kisline (asa). st segmentu višinskih akutni miokardni infarkt, v kombinaciji s asa v medicinsko zdravljenih bolnikih, ki izpolnjujejo pogoje za thrombolytic terapija. preprečevanje atherothrombotic in thromboembolic dogodkov v atrijska fibrilacija pri odraslih bolnikih z atrijsko fibrilacijo, ki imajo vsaj en dejavnik tveganja za žilne dogodke, niso primerni za zdravljenje z antagonisti vitamina k (vka) in ki imajo nizko tveganje krvavitve, clopidogrel je indiciran v kombinaciji s asa za preprečevanje atherothrombotic in thromboembolic dogodkov, vključno z možgansko kap.

Evropska unija - slovenščina - EMA (European Medicines Agency)

photonamic gmbh & co. kg - 5-aminolevulinična kislina hidroklorid - glioma - antineoplastična sredstva - gliolan je indiciran pri odraslih bolnikih za vizualizacijo malignih tkiv med operacijo malignih glioma (iii. in iv. svetovna zdravstvena organizacija).

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

atazanavir - kapsula, trda - atazanavir 300 mg / 1 kapsula - atazanavir

Evropska unija - slovenščina - EMA (European Medicines Agency)

takeda manufacturing austria ag - c1 inhibitor (človeški) - angioedem, dedno - c1-inhibitor, plazma izhajajo, zdravil, ki se uporabljajo v dedno angioedema - zdravljenje in preprečevanje napadov angioedemov pri odraslih, mladostnikih in otrocih (starih 2 leti ali več) z dednim angioedemom (hae). rutinsko preprečevanje angioedema napadov pri odraslih, mladostnikih in otrocih (6 let in več) s hudimi in ponavljajočimi se napadi dedno angioedema (hae), ki so nestrpni do ali nezadostno zaščitena z ustno preprečevanje zdravljenje, ali pri bolnikih, ki so neustrezno upravlja s ponovljenimi akutno zdravljenje.

Evropska unija - slovenščina - EMA (European Medicines Agency)

merck sharp and dohme b.v - posakonazol - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimikotiki za sistemsko uporabo - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 in 5. 1):- invasive aspergillosisnoxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections  4. 2 in 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. refractoriness je opredeljena kot napredovanje okužbe ali neuspeh za izboljšanje po najmanj 7 dni pred terapevtskih odmerkih učinkovito protiglivično zdravljenje. noxafil gastro-resistant tablets are also indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections 4. 2 in 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 in 5. 1):- invasive aspergillosisnoxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adult and paediatric patients from 2 years of age (see sections 4. 2 in 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. refractoriness je opredeljena kot napredovanje okužbe ali neuspeh za izboljšanje po najmanj 7 dni pred terapevtskih odmerkih učinkovito protiglivično zdravljenje. noxafil concentrate for solution for infusion is also indicated for prophylaxis of invasive fungal infections in the following adult and paediatric patients from 2 years of age (see sections 4. 2 in 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (gvhd) and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil gastro resistant powder and solvent for oral suspension is indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age (see sections 4. 2 in 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. refractoriness je opredeljena kot napredovanje okužbe ali neuspeh za izboljšanje po najmanj 7 dni pred terapevtskih odmerkih učinkovito protiglivično zdravljenje. noxafil gastro-resistant powder and solvent for oral suspension is indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2  years of age:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high  risk of developing invasive fungal infections;- haematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high  risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil oral suspension is indicated for use in the treatment of the following fungal infections in adults (see section 5. 1):- invazivne aspergillosis pri bolnikih z boleznijo, ki je neodzivna, da amphotericin b ali itraconazole ali pri bolnikih, ki ne prenašajo teh zdravil;- fusariosis pri bolnikih z boleznijo, ki je neodzivna, da amphotericin b ali pri bolnikih, ki so nestrpne amphotericin b;- chromoblastomycosis in mycetoma pri bolnikih z boleznijo, ki je neodzivna, da itraconazole ali pri bolnikih, ki so nestrpne itraconazole;- coccidioidomycosis pri bolnikih z boleznijo, ki je neodzivna, da amphotericin b, itraconazole ali fluconazole ali pri bolnikih, ki ne prenašajo teh zdravil;- Žrela kandidoza: kot prvo linijo zdravljenja pri bolnikih, ki imajo hude bolezni ali so immunocompromised, v kateri je odziv na aktualne terapija je pričakovati, da bo slaba. refractoriness je opredeljena kot napredovanje okužbe ali neuspeh za izboljšanje po najmanj 7 dni pred terapevtskih odmerkih učinkovito protiglivično zdravljenje. noxafil oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis.

Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan s.a.s - ribavirin - hepatitis c, kronični - antivirusi za sistemsko uporabo - ribavirin mylan je indiciran za zdravljenje kroničnega hepatitisa c in se uporabljajo le kot del kombinacije režim z interferon alfa-2b (odrasli, otroci (treh let in starejši) in mladostniki). ribavirin monoterapija se ne sme uporabljati. informacije o varnosti in učinkovitosti uporabe ribavirina z drugimi oblikami interferona (i. ne alfa-2b). preberite tudi interferon alfa-2b povzetek glavnih značilnosti zdravila (zdravila za predpisovanje informacije, zlasti za ta izdelek. naivna patientsadult patientsribavirin mylan je navedeno, v kombinaciji z interferonom alfa-2b za zdravljenje odraslih bolnikov z vsemi vrstami kroničnega hepatitisa c, razen za genotip 1, ki še niso bila obdelana, brez jeter decompensation, s povišano alanin aminotransferase (alt), ki so pozitivne za serum hepatitis-c-virus (hcv) rna. otroci in adolescentsribavirin mylan je navedeno, v kombinaciji režim z interferonom alfa-2b za zdravljenje otrok in mladostnikov, tri leta starosti in starejših, ki imajo vse vrste kroničnega hepatitisa c, razen za genotip 1, ki še niso bila obdelana, brez jeter decompensation, in ki so pozitivne za serum hcv rna. ko se odločate, da ne odloži zdravljenje do odrasle dobe, je pomembno upoštevati, da je kombinacija terapije povzročile zaviranja rasti. reverzibilnost zaviranja rasti je negotova. odločitev za zdravljenje mora biti od primera do primera (glej poglavje 4. predhodno zdravljenje-ni patientsadult patientsribavirin mylan je navedeno, v kombinaciji z interferonom alfa-2b za zdravljenje odraslih bolnikov s kroničnim hepatitisom c, ki so se predhodno odzvali (z normalizacijo alt ob koncu zdravljenja), da interferon alfa monotherapy ki pa so pozneje relapsed.

Evropska unija - slovenščina - EMA (European Medicines Agency)

merck sharp dohme ltd - boceprevir - hepatitis c, kronični - antivirusi za sistemsko uporabo - victrelis je indicirano za zdravljenje kroničnega hepatitisa c (chc) genotip 1 okužbe, v kombinaciji z peginterferon alfa in ribavirin pri odraslih bolnikih z nadomestiti bolezen jeter, ki so predhodno nezdravljenih ali ki niso prejšnje zdravljenje.